Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009893
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2001-02-02
Brief Title:
Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial Of Gemcitabine 5-Fluorouracil And Leucovorin In Patients With Measurable Unresectable Or Metastatic Biliary Tract Carcinoma Intrahepatic Extrahepatic Ampulla Of Vater And Gallbladder Carcinoma
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have unresectable or metastatic biliary tract or gallbladder cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have unresectable or metastatic biliary tract or gallbladder cancer
Detailed Description:
OBJECTIVES I Determine the 6-month survival and overall survival of patients with unresectable or metastatic biliary tract carcinoma or gallbladder cancer treated with gemcitabine fluorouracil and leucovorin calcium II Determine the tumor response in these patients treated with this regimen III Determine the toxicity of this regimen in these patients
OUTLINE Patients receive gemcitabine IV over 30 minutes followed by leucovorin calcium IV and fluorouracil IV over 5-10 minutes on days 1 8 and 15 Treatment repeats every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 1 year and then every 6 months for 4 years
OUTLINE Patients receive gemcitabine IV over 30 minutes followed by leucovorin calcium IV and fluorouracil IV over 5-10 minutes on days 1 8 and 15 Treatment repeats every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 1 year and then every 6 months for 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068421 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02370 | REGISTRY | None | None |